États-Unis - anglais - NLM (National Library of Medicine)

fresenius kabi usa, llc - bortezomib (unii: 69g8bd63pp) (bortezomib - unii:69g8bd63pp) - bortezomib 1 mg in 1 ml - bortezomib for injection is indicated for the treatment of adult patients with multiple myeloma. bortezomib for injection is indicated for the treatment of adult patients with mantle cell lymphoma who have received at least 1 prior therapy. bortezomib for injection is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, boric acid or glycine. reactions have included anaphylactic reactions [see adverse reactions (6.1)] . bortezomib for injection is contraindicated for intrathecal administration. fatal events have occurred with intrathecal administration of bortezomib. risk summary based on its mechanism of action [see clinical pharmacology (12.1)] and findings in animals, bortezomib for injection can cause fetal harm when administered to a pregnant woman. there are no studies with the use of bortezomib in pregnant women to inform drug-associated risks. bortezomib caused embryo-fetal lethality in rabbits at doses lower than the clinical dose [see data] . advis

Israël - anglais - Ministry of Health

teva israel ltd - bortezomib - powder for solution for injection - bortezomib 3.5 mg - bortezomib - bortezomib teva is indicated for the treatment of patients with multiple myeloma. bortezomib teva is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. bortezomib teva in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation

Israël - anglais - Ministry of Health

taro international ltd, israel - bortezomib - powder for solution for injection - bortezomib 3.5 mg/vial - bortezomib - bortezomib is indicated for the treatment of patients with multiple myeloma.bortezomib is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. bortezomib in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.

Union européenne - anglais - EMA (European Medicines Agency)

pfizer europe ma eeig - bortezomib - multiple myeloma - other antineoplastic agents - bortezomib hospira as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.bortezomib hospira in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.bortezomib hospira in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.bortezomib hospira in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.

Union européenne - anglais - EMA (European Medicines Agency)

sun pharmaceutical industries (europe) b.v. - bortezomib - multiple myeloma - antineoplastic agents - bortezomib sun as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.bortezomib sun in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.bortezomib sun in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.bortezomib sun in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.

Union européenne - anglais - EMA (European Medicines Agency)

accord healthcare s.l.u. - bortezomib - multiple myeloma - antineoplastic agents - bortezomib accord as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.bortezomib accord in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high‑dose chemotherapy with haematopoietic stem cell transplantation.bortezomib accord in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high‑dose chemotherapy with haematopoietic stem cell transplantation.bortezomib accord in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.

Union européenne - anglais - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - bortezomib - multiple myeloma - antineoplastic agents - bortezomib as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.bortezomib in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.bortezomib in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.bortezomib in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - bortezomib, quantity: 3.5 mg - injection, powder for - excipient ingredients: mannitol - bortezomib sandoz, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy.,bortezomib sandoz, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma.,bortezomib sandoz is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.,bortezomib sandoz in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

Israël - anglais - Ministry of Health

neopharm (israel) 1996 ltd - bortezomib - powder for solution for injection - bortezomib 3.5 mg/vial - bortezomib - multiple myelomabortezomib fresenius kabi is indicated for the treatment of adult patients with multiple myeloma.mantle cell lymphomabortezomib fresenius kabi for injection is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. bortezomib fresenius kabi in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

interpharma pty ltd - bortezomib, quantity: 3.5 mg - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; sodium hydroxide; water for injections; mannitol - bortezomib ever pharma, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy. bortezomib ever pharma, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. bortezomib ever pharma is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. bortezomib ever pharma in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.